Johnson & Johnson’s subsidiary Janssen made headlines again in August 2023 when the FDA approved its product talquetamab under the agency’s accelerated approval program.
Delhi, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Johnson & Johnson’s subsidiary Janssen Pharmaceutical Inc. made headlines again in August 2023 when the FDA approved its product talquetamab under the agency’s accelerated approval program. Talquetamab is marketed under the brand name Talvey, and is a first-in-class bispecific antibody indicated for the treatment of adult patients with multiple myeloma whose cancer has returned or did not respond to prior therapies despite having undergone a minimum four previous lines of treatment, which includes a proteasome inhibitor, an immunomodulatory medication, and an anti-CD38 antibody. Talvey is also the second bispecific antibody approved for the treatment of multiple myeloma.
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As mentioned above, Talvey belongs to the bispecific antibody drug class, a treatment modality that has now transformed how certain cancers are treated. As opposed to their predecessor monoclonal antibodies, bispecific antibodies are designed to target two epitopes, which gives them extraordinary specificity and targeting ability. In the case of Talvey, the antibody is designed to target the G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells, and the CD3 receptor on the surface of T cells. By binding to these proteins, Talvey bridges the gap between T cells and malignant myeloma cells, thereby acting as a T cell engager.
Talvey was approved based on the results of the phase II MonumenTAL-1 (MMY1001) research, which was a single-arm, open-label, multicenter investigation. The trial included 187 people with multiple myeloma who had previously undergone at least four systemic treatments. They were divided into two groups, with one receiving 0.4 mg/kg Talvey dosages weekly and the other receiving 0.8 mg/kg every two weeks. The objective response rate (ORR) in patients receiving 0.4 mg/kg weekly was 73, while the ORR in those getting 0.8 mg/kg biweekly was 73.6%. An estimated 85% of respondents kept responding for at least 9 months.
The findings of this and preceding experiments enabled researchers to devise an effective dosing schedule for Talvey. As a result, Talvey was approved as a weekly or biweekly subcutaneous (SC) injection after an initial step-up phase, offering physicians the flexibility to determine the optimal treatment regimen for patients.
The MonumenTAL-1 clinical trial participants most frequently experienced pyrexia, cytokine release syndrome (CRS), changes in taste, nail disorder, pain in the muscles and joints, skin disorder, rash, tiredness, decreased weight, mouth dryness, dry skin, trouble swallowing, respiratory tract infection, diarrhea, low blood pressure, and headache. Low neutrophil, white blood cell, lymphocyte, and hemoglobin counts were the most common Grade 3 or 4 laboratory abnormalities. Talquetamab is only offered through a restricted Janssen program under a Risk Evaluation and Mitigation Strategy (REMS), known as the Tecvayli-Talvey REMS, due to the possibility of cytokine release syndrome and neurologic toxicity, which includes immune effector cell-associated neurotoxicity syndrome (ICANS).
Talvey’s FDA review was carried out as part of Project Orbis, a program of the organization’s Oncology Center of Excellence. International partners can simultaneously submit and evaluate oncology medications using the framework provided by Project Orbis. Regardless of whether the medicine has FDA approval, cooperation between international regulators may enable patients with cancer to obtain products earlier in nations where there may be considerable delays in regulatory filings.
Talvey is also being evaluated by the European Medicines Agency. The Committee for Medicinal Products for Human Use (CHMP), July 2023, suggested that Talvey be granted conditional marketing authorization to treat multiple myeloma. The EMA conditional marketing authorization is issued to a medicine, similar to the FDA’s quick approval process, where it meets an unmet medical need and the immediate availability outweighs the risk associated with the need for more data. In preparation for a normal approval, the FDA and EMA will subsequently receive extensive clinical data from Janssen and Johnson & Johnson.
Therefore, the approval of Talvey has increased the arsenal of treatments available to treat relapsed or refractory multiple myeloma patients. Though it has several manageable adverse effect as mentioned above, being a bispecific antibody, it is also expected to have less side-effects arising from off-target interactions in the body. Approvals for Talvey in other regions are anticipated by the end of 2024.
Neeraj Chawla Kuick research Research Head neeraj@kuickresearch.com https://www.kuickresearch.com
